Tag: silver-spring
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Clovis’s ovarian cancer drug wins accelerated FDA approval
(Reuters) – The U.S. Food and Drug Administration said on Monday it granted accelerated approval to Clovis Oncology Inc's ovarian cancer drug in patients whose disease advanced despite chemotherapy. The drug, Rubraca, secured approval for patients whose tumors have a specific gene mutation called BRCA – identified by an FDA-approved companion diagnostic test, the FDA…
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Dynavax says FDA rejects its hepatitis B vaccine
(Reuters) – The U.S. Food and Drug Administration rejected Dynavax Technologies Corp's marketing application for its hepatitis B vaccine, Heplisav-B, for the second time in three years, sending the company's shares tumbling 71 percent in premarket trade. The drug developer said on Monday it received a “complete response letter” from the FDA, seeking information about…
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FDA’s sharing of grand jury information comes under criticism
An office inside the Food and Drug Administration routinely shares details internally about criminal matters pending before grand juries, a step some lawyers say may run afoul of rules meant to safeguard investigations. FDA agents send updates about anticipated grand jury testimony and indictments to more than two dozen people, many of whom have nothing to…
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FDA approves Shire’s keenly-watched eye drug
(Reuters) – The U.S. Food and Drug Administration on Monday approved Shire Plc's lifitegrast eye drops for treating signs and symptoms of dry eye disease, allowing the company to bring to market its most important pipeline medicine. Lifitegrast, which will be marketed as Xiidra in the United States, is expected to launch in the third…
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U.S. FDA calls for sharp reduction in salt added to foods
(Reuters) – U.S. health officials recommended cutting the amount of salt added to foods by about a third, according to proposed guidelines that are likely to have a wide-ranging impact on the processed food industry in the United States. Increased sodium intake is linked to high blood pressure, which can lead to heart disease and…
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U.S. FDA calls for sharp reduction in salt added to foods
(Reuters) – U.S. health officials recommended cutting the amount of salt added to foods by about a third, according to proposed guidelines that are likely to have a wide-ranging impact on the processed food industry in the United States. Increased sodium intake is linked to high blood pressure, which can lead to heart disease and…
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Doctor: Baby born in US to mom with Zika has birth defect
HACKENSACK, N.J. (AP) — A Honduran woman with the Zika virus gave birth in New Jersey to a baby girl with birth defects that appear to be caused by the mosquito-borne virus, one of her doctors said.
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Doctor: Baby born in US to mom with Zika has birth defect
HACKENSACK, N.J. (AP) — A Honduran woman with the Zika virus gave birth in New Jersey to a baby girl with birth defects that appear to be caused by the mosquito-borne virus, one of her doctors said.
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Ousted Maldives president forms opposition-in-exile group
Mohamed Nasheed, a former president of the Maldives now in exile in Britain after being ousted from office and jailed in his country, formed an opposition group on Wednesday aimed at toppling the government of President Abdulla Yameen. Best known as a paradise for wealthy tourists, the Indian Ocean archipelago has been mired in political…
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Brazil’s Temer says sacrifices needed to end ‘bloated’ state
BRASILIA (Reuters) – Brazil's interim President Michel Temer said on Wednesday that his government will not cut spending on health and education, although sacrifices are needed to balance public accounts and restore economic growth. “There is no longer any room in Brazil for a bloated and inefficient state,” Temer said in a speech in which…